Cleared Special

Comet-PLUS

K172711 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Neurology
Nov 2017
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K172711 is an FDA 510(k) clearance for the Comet-PLUS, a Standard Polysomnograph With Electroencephalograph (Class II — Special Controls, product code OLV), submitted by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA). The FDA issued a Cleared decision on November 3, 2017, 56 days after receiving the submission on September 8, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number K172711 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2017
Decision Date November 03, 2017
Days to Decision 56 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OLV — Standard Polysomnograph With Electroencephalograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1400
Definition Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain And Other Signals (such As Electromyography, Respiratory And/or Oximetry Signals) For Sleep Recordings. May Also Be Used To Allow On-screen Review, User-controlled Annotation And User-controlled Marking Of Data.